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Clinical evaluation of the ResistancePlus MG FleXible test on the GeneXpert Infinity-48s instrument: a near-patient assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance.
Diagnostic Microbiology and Infectious Disease ( IF 2.9 ) Pub Date : 2020-04-17 , DOI: 10.1016/j.diagmicrobio.2020.115062
Miguel Fernández-Huerta 1 , Paula Salmerón 1 , Aroa Silgado 1 , Mateu Espasa 2 , Tomàs Pumarola 1 , Suhella Tulsiani-Drud 3 , María-Jesús Barberá 4 , Yannick Hoyos-Mallecot 1 , Judit Serra-Pladevall 1
Affiliation  

Antibiotic resistance in Mycoplasma genitalium (MG) is rising globally, especially to macrolides. In response to this challenge, assays reporting both the detection of MG and macrolide resistance-mediating mutations (MRMM) allow therapy to be tailored to the individual. The study evaluated the performance of the ResistancePlus® MG FleXible assay for the detection of MG and MRMM. Overall, the test performed well for the detection of MG compared to the Allplex™ STI Essential assay, used as a reference, with a kappa value of 0.926 (95% CI, 0.863–0.990). The kit also performed well for the detection of MRMM when compared with Sanger sequencing of the 23S rRNA gene, with a kappa value of 0.901 (95% CI, 0.807–0.996). The rate of MRMM in MG among the study population was 41.8%. In conclusion, the ResistancePlus® MG FleXible is a rapid, simple and accurate cartridge-based assay for simultaneous detection of MG and MRMM in clinical settings.



中文翻译:

在GeneXpert Infinity-48s仪器上进行的ResistancePlus MG FleXible测试的临床评估:用于同时检测生殖器支原体和大环内酯类药物耐药性的近患者检测方法。

生殖支原体中的抗生素耐药性(MG)在全球范围内呈上升趋势,尤其是对大环内酯类药物而言。为了应对这一挑战,报告检测到MG和大环内酯类药物介导的突变(MRMM)的检测方法使得治疗可以针对个体进行。该研究评估了用于检测MG和MRMM的ResistancePlus®MG FleXible分析的性能。总体而言,与用作参考的Allplex™STI Essential分析相比,该测试在检测MG方面表现良好,kappa值为0.926(95%CI,0.863–0.990)。与Sanger测序的23S rRNA基因相比,该试剂盒对MRMM的检测也表现良好,kappa值为0.901(95%CI,0.807-0.996)。研究人群中MG的MRMM率为41.8%。总之,ResistancePlus®MG FleXible是一种快速,

更新日期:2020-04-20
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